PRODIGY: A Phase III Study of Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 Versus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer
- PURPOSE Adjuvant chemotherapy after D2 gastrectomy is standard for resectable locally advanced gastric cancer (LAGC) in Asia. Based on positive findings for perioperative chemotherapy in European phase III studies, the phase III PRODIGY study (ClinicalTrials.gov identifier: NCT01515748) investigated whether neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) followed by surgery and adjuvant S-1 could improve outcomes versus standard treatment in Korean patients with resectable LAGC.
PATIENTS AND METHODS Patients 20-75 years of age, with Eastern Cooperative Oncology Group performance status 0-1, and with histologically confirmed primary gastric or gastroesophageal junction adenocarcinoma (clinical TNM staging: T2-3N+or T4Nany) were randomly assigned to D2 surgery followed by adjuvant S-1 (40-60 mg orally twice a day, days 1-28 every 6 weeks for eight cycles; SC group) or neoadjuvant DOS (docetaxel 50 mg/m(2), oxaliplatin 100 mg/m(2) intravenously day 1, S-1 40 mg/m(2) orally twice a day, days 1-14 every 3 weeks for three cycles) before D2 surgery, followed by adjuvant S-1 (CSC group). The primary objective was progression-free survival (PFS) with CSC versus SC. Two sensitivity analyses were performed: intent-to-treat and landmark PFS analysis.
RESULTS Between January 18, 2012, and January 2, 2017, 266 patients were randomly assigned to CSC and 264 to SC at 18 Korean study sites; 238 and 246 patients, respectively, were treated (full analysis set). Follow-up was ongoing in 176 patients at data cutoff (January 21, 2019; median follow-up 38.6 months [interquartile range, 23.5-62.1]). CSC improved PFS versus SC (adjusted hazard ratio, 0.70; 95% CI, 0.52 to 0.95; stratified log-rank P = 5.023). Sensitivity analyses confirmed these findings. Treatments were well tolerated. Two grade 5 adverse events (febrile neutropenia and dyspnea) occurred during neoadjuvant treatment.
CONCLUSION PRODIGY showed that neoadjuvant DOS chemotherapy, as part of perioperative chemotherapy, is effective and tolerable in Korean patients with LAGC. (C) 2021 by American Society of Clinical Oncology
- 강윤구; 국명철; 김균지; 김범수; 김용우; 김인호; 김종광; 김진용; 김학규; 김현기; 노성훈; 라선영; 류백렬; 류성완; 박영규; 박영수; 박조현; 범성훈; 설지영; 손태일; 오상철; 유문원; 유민희; 유창학; 육정환; 이남수; 이상호; 이연주; 이종석; 이지훈; 장대영; 장우진; 정미란; 정익주; 조상희; 최진혁; 허미화
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- Adenocarcinoma - mortality; Adenocarcinoma - pathology; Adenocarcinoma - therapy; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Chemotherapy; Adjuvant; Docetaxel - adverse effects; Docetaxel - therapeutic use; Drug Combinations; Esophagogastric Junction - drug effects; Esophagogastric Junction - pathology; Esophagogastric Junction - surgery; Female; Gastrectomy - adverse effects; Gastrectomy - mortality; Humans; Male; Middle Aged; Neoadjuvant Therapy - adverse effects; Neoadjuvant Therapy - mortality; Neoplasm Staging; Oxaliplatin - adverse effects; Oxaliplatin - therapeutic use; Oxonic Acid - adverse effects; Oxonic Acid - therapeutic use
Progression-Free Survival; Republic of Korea; Stomach Neoplasms - mortality; Stomach; Neoplasms - pathology; Stomach Neoplasms - therapy; Tegafur - adverse effects; Tegafur - therapeutic use; Time Factors; Young Adult
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